Z-1813-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- August 12, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units (5/box) US; 83 units(5/box) OUS
Product Description
Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Reason for Recall
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Distribution Pattern
Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
Code Information
UDI-DI: 00821925044531 Lot Numbers: CA191167 CA191168 CA191169 CA191170